Device recall
Z-2229-2008: Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM…
FDA device recall · Class II · Naviscan PET Systems
Key facts
| Recall number (Z-number) | Z-2229-2008 |
|---|---|
| Recall event | 48694 |
| Product | Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology. |
| Product code | KPS |
| Recalling firm | Naviscan PET Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2009 |
| 510(k) numbers | K032063 |
| FEI number | 3005945241 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database